HidraMed Solutions, the company who developed HidraWear products was founded by Suzanne, a fellow HS patient. Suzanne began the journey to developing the first product back in 2013, when she simply wanted to be able to dress her armpits quickly and get on with her day. She spent 2 years working with a designer, who ultimately couldn’t do what was required. So she approached a local government innovation office and asked for help. A small grant of €5,000 led her to working with a design college who developed the first prototype for HidraWear.
A little bit of progress with HidraWear Products
Throughout the next year, Suzanne researched HS wound care. She found that she was not alone in her struggles to manage her HS wounds. So she spoke to lots of other people living with HS. Realising that the problem was bigger than she thought, and that HS wounds were severely impacting people’s lives, Suzanne took her prototype and applied for a programme at the National University of Ireland – BioExel. She was accepted and was trained for 6 months in different areas of medical device development. At the end of the 6 months, she committed to HidraWear full time to fully develop and launch her first product – HidraWear AX – the crop top for women with HS in the armpit.
The next steps
A lot of people ask about other products and when will they be coming. So we wanted to share a bit about the company, and what we are working on now. HidraMed Solutions is a small company. In January 2018, it was just Suzanne. In June and July of 2018, Suzanne pitched her idea in some “shark tank” like competitions. She won some funding so she could finally hire her first team member – Conan Cavanagh. Conan is a specialist in the design and development of medical products.
Together, they worked with various experts to develop HidraWear as much as they could. But they needed more people on the team, and so they needed more funding. They pitched at almost every opportunity, and were successful in securing additional funding for the company. In 2019, they took on a larger investment from venture investors, private parties and government agencies. They could hire more team members and launch the first product.
New HidraWear Products
Because the company is small, everything is done in stages. Larger wound care companies have huge budgets and resources for product development. But that is not the case for small companies. And so, the team, now 5 people have launched HidraWear. But, we have been working quietly away in the background on some other products and we are delighted to share an update with you today.
We are so pleased to share some details of our next products with you! First up we have the male T-Shirt, which works in a similar fashion to the female top, but is designed like a T-Shirt. Dressings can be placed and retained in the armpit, upper arm and side of the upper chest.
Next we have the HidraWear underwear. The female version are similar to cycling shorts in style. They allow the placement and retention of dressings in the groin, inner thigh, pubic bone, lower abdomen and buttocks. And they have a special opening that allows users to use the bathroom without removing them. So there will be no more holding onto dressings, or dressings falling down the toilet!
The male shorts are designed to fit like a snug pair of undies. These are super soft and not constricting. They allow the placement and retention of dressings in all the areas mentioned above, and also in the ano-genital region.
We have nearly finalised the designs and cannot wait to share more updates with you in the coming months.
So, the HidraWear team have designed some new HidraWear products…but when will you get them?
From previous blogs you will know that regulatory compliance is one of the most, if not the single most, challenging aspects of launching a medical product. The good news is that we have successfully navigated the regulatory waters in the past, when creating the HidraWear AX for Women. The company achieved CE marking and FDA registration for the Axilla garment. We also achieved ISO 13485:2016 accreditation for the Company. Not an easy thing to do for a small team like us!
Now the HidraWear team must make sure all our I’s are dotted and T’s are crossed by performing some tests on the new products. This is known as Design Verification and Validation. Along the design process, the team complete Design Reviews to ensure all regulatory (ISO/MDR/FDA) requirements are met. You can read more about there here, here and here. But be warned….regulatory compliance documents are not for the faint hearted! Our quality engineer Laura oversees all of this documentation. And honestly, I think she has some kind of superhuman powers!
The final hurdles
Conan, Laura and Suzanne, along with industry experts will oversee the testing. Once all this testing, documenting, and recording is complete, it will be reviewed by the quality department, to ensure only top-quality products are going to be leaving the facility and getting dispatched to you. All our products must be registered with regulatory authorities in the countries we sell into so there is always full traceability of our products and evidence that they meet all the regulations in these countries. Sometimes all these activities can take up to 9-12 months from design freeze.
We Cannot wait to share more with you as we progress closer to the final stages. Thank you for your support so far. We are one step closer to easy HS wound care for all.